Regulatory Enablement Johner Institute serves medical device manufacturers with comprehensive regulatory and quality system services (ISO 14971, ISO 13485, 21 CFR Part 820, FDA/IEC documentation) and usability testing across Europe and the USA, presenting opportunities to upsell expanded regulatory affairs, post-market surveillance, and clinical evaluation services.

Quality Systems Focus The firm specializes in establishing and auditing quality management systems and risk management files, positioning them to cross-sell continuous compliance programs, internal audits, and ongoing quality improvement engagements with device makers seeking ISO 13485 alignment and regulatory readiness.

End-to-End Documentation With capabilities spanning risk management, software lifecycle documentation, clinical evaluations, and post-market surveillance, there are cross-sell opportunities to package integrated documentation services for new product development and regulatory submissions.

Clinical and Usability Expertise Johner Institute conducts usability testing and clinical investigations, enabling sales to target manufacturers pursuing robust human factors engineering, real-world usability validation, and evidence generation to support market approvals and 510(k)/PMAs.

Digital Reach & Brand Cred Leveraging their tech stack and Trustpilot presence, there is potential to offer enhanced market intelligence, customer feedback programs, and digital compliance training as value-added services to strengthen manufacturers’ go-to-market readiness and customer trust.